Drug Shortages and Compounding: What Is Actually Allowed

A compounding pharmacy can sometimes prepare a medication that is hard to find, but not simply because it is hard to find. Federal compounding rules turn on whether an equivalent commercial product exists, what strengths and dose forms that product comes in, and whether the drug appears on FDA's shortage list. This page walks through where those lines fall, using the pediatric ibuprofen and acetaminophen scarcity of late 2022 as a worked example rather than as the subject.

What is a drug shortage?

A drug shortage is a supply interruption in a drug product, usually traced back to manufacturing, raw material sourcing, quality problems at a plant, a company leaving the market, or demand rising faster than production. It is a supply-side event, and it happens upstream of the pharmacy counter.

FDA maintains a public drug shortage database and posts each affected product with a reason and a status. Federal law requires manufacturers to notify FDA of interruptions or discontinuations of certain products, which is how most entries reach the list. A product stays listed until FDA determines supply meets demand again.

Retail scarcity is not the same thing. Empty shelves at a grocery store during a bad respiratory season can reflect buying patterns and distribution rather than a listed manufacturing shortage. That distinction is not academic, because the compounding rules described below hang on the formal list, not on how a store looked last week.

Can a compounding pharmacy just make a drug that is in short supply?

Usually not, and the reason is a specific provision of federal law. Section 503A of the Federal Food, Drug, and Cosmetic Act sets the conditions a 503A pharmacy has to meet, and one of them is that the compounded preparation must not be what the statute calls "essentially a copy of a commercially available drug product."

That rule exists deliberately. FDA-approved products carry a manufacturing, testing and post-market surveillance record that a compounded preparation does not, so the law steers patients toward the approved product whenever an appropriate one is on the market. Compounding is meant to fill the gaps that approved products leave, not to run alongside them. The difference between a compounding pharmacy and a retail pharmacy comes down largely to which of those roles each one plays.

So a back-ordered product at one wholesaler does not, on its own, open the door. If an equivalent commercial product exists and is available, a 503A pharmacy generally may not prepare a copy of it, no matter how inconvenient the back order is for the patient standing at the counter.

What does FDA's shortage list actually change?

This is the legal hook that matters. Under 503A, a drug that appears on FDA's shortage list is not treated as "commercially available" for purposes of the copy restriction. Once a product is listed, the bar on preparing something essentially the same as it no longer applies in the way it otherwise would, and a prescriber may write for a compounded version while the listing stands.

Two consequences follow. First, the exception is tied to the listing, so it can close again when FDA removes the entry. Second, it is the drug and dose form on the list that matters, not a general sense that a category is tight.

The other piece of "essentially a copy" is that a preparation is not a copy when a prescriber determines that a change in the formulation makes a clinical difference for that individual patient. A different strength, a liquid instead of a tablet, or the removal of an ingredient a patient reacts to can each be that change, and the prescriber has to make and document the determination.

The last row carries real weight. FDA keeps a separate list of drugs withdrawn or removed from the market because they were found unsafe or ineffective, and those may not be compounded at all. A drug leaving the market for commercial reasons and a drug leaving it for safety reasons look identical on a shelf and are treated as opposites in the regulations.

What can a compounding pharmacy realistically do during a shortage?

The useful question is rarely "can you make the missing bottle." It is "what does this patient actually need, and is there a preparation the rules allow." In practice the answers cluster into a few shapes.

A different strength is the most common one. Manufactured products come in the strengths that made commercial sense, and a prescriber may need one that was never produced, which is why compounded low dose atropine ophthalmic drops exist alongside the commercial concentrations.

A liquid is the next most common. Children, older adults, stroke patients and anyone fed through a tube may need a drug that only comes as a tablet or capsule, and custom oral suspensions are prepared for exactly that reason.

Bayview groups those preparations under the digestive and GI section of the catalog, though the same swallowing problem shows up in every therapeutic area.

An allergen-free or dye-free vehicle is a third. When the commercial liquid contains a dye, a preservative or a sweetener a patient cannot tolerate, the drug itself is not the obstacle and the base is. Compounding lets the prescriber keep the drug and change everything around it.

A discontinued or never-made dose form is the fourth. Leucovorin oral suspension exists because prescribers needed a liquid the manufacturer does not sell.

The same pattern produces compounded omeprazole for patients who cannot swallow a capsule, and it repeats across the catalog under different drug names.

Combination preparations follow the same reasoning. No manufacturer sells a single product combining the ingredients in a magic mouthwash, so the combination is prepared to the prescriber's written formula.

Route changes are the last shape. A drug sold only as a tablet may be ordered as a topical gel, which is where compounded diclofenac comes from.

Sites the commercial product does not reach drive the rest. Nystatin suppositories and nasal spray are ordered because the marketed oral forms were not designed for those routes.

What can a compounding pharmacy not do?

It cannot replace a manufactured product at scale. A 503A pharmacy prepares medications for individually identified patients on valid prescriptions, one order at a time, in a lab, not on a production line. That model does not substitute for a factory and is not designed to.

It cannot act as a supply chain. Compounding pharmacies buy active pharmaceutical ingredients from suppliers who are themselves affected by the same raw material and manufacturing pressures that cause shortages in the first place, so a national shortage is not something any single pharmacy resolves.

It cannot compound a drug that was withdrawn for safety reasons, as noted above, and it cannot decide on its own that a copy is warranted. That determination belongs to the prescriber and has to rest on a clinical difference for the patient in front of them.

What happened during the pediatric ibuprofen and acetaminophen scarcity?

In late 2022, families across the United States had trouble finding children's liquid ibuprofen and acetaminophen during an unusually heavy respiratory illness season. Coverage at the time described empty shelves, purchase limits at major retailers, and pharmacies fielding calls from parents who could not find a dose form their child could swallow.

Compounding pharmacies, Bayview included, took prescriptions for compounded oral analgesic suspensions during that period. The episode is worth keeping because it shows the whole framework in one place: an adult can take a tablet, a two year old cannot, and the gap between those two facts is where compounding sits. The retail situation eased, and the episode is now history rather than news.

It also illustrates the distinction drawn earlier, because retail scarcity and a formal FDA shortage listing are separate things and the compounding analysis differs depending on which one applies. Anyone assessing a current shortage should check the status of the specific product rather than reasoning from what happened in 2022.

Do you need a prescription for something sold over the counter?

Yes. Ibuprofen and acetaminophen are sold over the counter as manufactured products, but a compounded preparation of either is a prescription item and is dispensed only on a valid prescription written for a named patient. The over-the-counter status of the commercial product does not carry over.

The prescriber decides whether a compounded preparation is appropriate, which drug and strength to order, and how it should be given. A pharmacy does not make that call, and nothing on this page is a dose recommendation. If you are having trouble finding a medication, that conversation starts with your prescriber, not with a search for a pharmacy that will make it. Prescribers who want to discuss a preparation can reach the pharmacy through the information for providers page.

What Bayview compounds in this space

On a prescriber's order, Bayview prepares oral liquids in patient-specific strengths and flavors, including preparations intended for administration through a feeding tube, with pricing that starts at $71. Preparations are made under USP 795 non-sterile compounding standards in Warwick, Rhode Island.

The full range of preparations, including the strengths and routes available for each, is listed in the searchable catalog of compounded medications.

Questions about cost, insurance, shipping and the states where Bayview is licensed are answered on the frequently asked questions page. Compounded preparations are not FDA-approved products, and they are generally not billed through insurance benefits.

Talk to your prescriber

If a medication you or your child takes has become difficult to find, bring it to your prescriber with the specific product, strength and dose form written down. They can check whether the item is on FDA's shortage list, whether an approved alternative exists, and whether a compounded preparation is appropriate for your situation.

If you are new to this and want the background first, start with the difference between compounding and retail pharmacies, which covers what each type of pharmacy is set up to do.

For a sense of what compounding looks like when a needed strength was simply never manufactured, the piece on low dose atropine drops for myopia progression works through one example in detail.

And if you are trying to work out how to get a prescription filled locally, finding a compounding pharmacy near you covers what to ask before you send a prescription anywhere.

The order form Bayview posted during the 2022 scarcity is still linked below.